1.1 Background

In the last decade, there has been a global upsurge in the use of traditional medicine (TM) and complementary and alternative medicines (CAM) in both developed and developing countries. Today, therefore, certain forms of traditional, complementary and alternative medicines play an increasingly important role in health care and health sector reform globally. Hence, the safety and efficacy, as well as the quality control, of traditional medicine and complementary and alternative medicines have become important concerns for both health authorities and the public (2).

The development of traditional medicines has been influenced by the different cultural and historic conditions in which they were first developed. Their common basis is a holistic approach to life, equilibrium between the mind, body and environment, and an emphasis on health rather than on disease. Generally, the treatment focuses on the overall condition of the individual patient, rather than on the ailment or disease. This more complex approach makes evaluation highly difficult, since so many factors must be taken into account.

Therefore, therapies and theories of TM/CAM differ from country to country and region to region. The commercial value of herbal medicines on the international market is high and increasing greatly. Unfortunately, there is a lack of common standards and understanding and appropriate methods for evaluating traditional medicine to ensure the safety, efficacy and quality control of TM/CAM. Therefore, sharing national experience and information is crucial.

Challenges

Countries face major challenges in the development and implementation of the regulation of traditional, complementary/alternative and herbal medicines. These challenges are related to regulatory status, assessment of safety and efficacy, quality control, safety monitoring and lack of knowledge about TM/CAM within national drug regulatory authorities.

Before manufactured drugs came into widespread use, herbal medicines played an important role in human health. Reviewing the history of the development of medicines, we see that most herbal medicines were originally derived from foods. Most manufactured drugs were developed from medicinal plants. The influence of culture and history on the use of herbal medicines differs from country to country and region to region, and they still have a major impact on the use of herbal medicines in modern societies. Therefore, there are great differences between Member States in the definition and categorization of herbal medicines. A single medicinal plant may be defined as a food, a functional food, a dietary supplement or a herbal medicine in different countries, depending on the regulations applying to foods and medicines in each country. This makes it difficult to define the concept of herbal medicines for the purposes of national drug regulation and also confuses patients and consumers.

In order to meet these challenges, the WHO Traditional Medicine Strategy (2) was developed, with its four primary objectives: framing policy; enhancing safety, efficacy and quality; ensuring access; and promoting rational use Resolution WHA56.31 on traditional medicine was adopted at the Fifty sixth World Health Assembly in May 2003. The resolution requested WHO to support Member States by providing internationally acceptable guidelines and technical standards and also evidence based information to assist Member States in formulating policy and regulations to control the safety, efficacy and quality of traditional medicines. Furthermore, the recommendation from the workshop on herbal medicines at the Eleventh International Conference of Drug Regulatory Authorities (ICDRA - Madrid, Spain, 16-19 February 2004) requested that regulatory agencies should work together to make the best use of scientific resources related to herbal medicines, and stated that sharing national experience and information was crucial. It also requested WHO to facilitate these activities, e.g. by providing updated monographs on medicinal plants and technical/regulatory guidance.